Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Prescription event monitoring
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

METFORMIN

Medical condition to be studied

Diabetes mellitus
Renal impairment
Population studied

Short description of the study population

Patients who were diagnosed with Type 2 Diabetes Mellitus (T2DM) with or without therapy. Patients were be included if: 1) had at least one measure of Glomerular Filtration Rate (GFR) between 2007-2012 or their chronic kidney disease (CKD) measured; 2) regardless of T2DM diagnoses date, 3) with or without therapy, 4) regardless of whether they were using insulin concomitant to other OAD drugs, and 5) have at least 1 follow-up during the study period.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Renal impaired

Estimated number of subjects

135000
Study design details

Main study objective

To estimate the incidence of lactic acidosis associated with metformin use in patients with moderate renal impairment (GFR 30-59ml/min) compared to patients with a GFR >60 ml/min.

Data analysis plan

Data analysis will consist of incidence rates in 100,000 person-years of lactic acidosis in patients with T2DM using metformin and having different CKD staging. A secondary analysis of the incidence of LA in patients using Metformin versus those using other antidiabetic drugs by stages of CKD will be performed. Lactic acidosis includes both cases of fatal and cases of non-fatal lactic acidosis. Upper and lower limits of 95% confidence intervals will be given.